Cleared Traditional

K981243 - BIOSTRIDE FREE T4 EIA TEST KIT

K981243 is an FDA 510(k) clearance for BIOSTRIDE FREE T4 EIA TEST KIT, manufactured by Biostride Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K981243 · Biostride Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
84d
Days
Class 2
Risk

K981243 is an FDA 510(k) clearance for the BIOSTRIDE FREE T4 EIA TEST KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Biostride Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biostride Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981243

510(k) Number K981243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date June 29, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 77
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K981243.
ABBOTT ARCHITECT FREE T4
K983417 · Abbott Laboratories · Nov 1998
FREE T4 MICROWELL EIA, MODEL #7019
K982954 · Biomerica, Inc. · Sep 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · Beckman Instruments, Inc. · Jul 1998
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
K980819 · Biocircuits Corp. · Apr 1998
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · Sealite Sciences, Inc. · Dec 1997
IMMULITE FREE T4 (2-STEP)
K971792 · Diagnostic Products Corp. · Jul 1997